Daewoong Pharmaceutical said on the 17th that its gastroesophageal reflux disease treatment "Fexuclu 40 mg (ingredient name fexuprazan)" has obtained marketing approval in Indonesia.
Fexuclu showed rapid onset and treatment efficacy in local patients through an investigator-initiated clinical study conducted in Indonesia last year. To expand the indication to gastric ulcer treatment, the company on the 10th applied to the Ministery of Food and Drug Safety for a multinational phase 3 clinical trial plan (IND) to be conducted jointly in Korea and Indonesia.
The local market environment is also positive. Proton pump inhibitors (PPI), used as first-line therapy for gastroesophageal reflux disease in Indonesia, have been noted for limitations such as slow onset and low dosing convenience. By contrast, Fexuclu has strengths in improving early symptoms and controlling nighttime symptoms based on fast, stable acid suppression and a comparatively long duration of action.
Accordingly, demand for P-CAB class treatments is expected to expand, centered on patients who have not achieved sufficient effects with existing therapy. In Japan, P-CAB prescriptions have surpassed 60%, and in Korea they have risen to about 35%.
Global expansion is also accelerating. Fexuclu has entered 30 countries and obtained marketing approvals in 16, including Korea, Indonesia, China, Mexico, and India. It is being sold in six of them, with a launch in China ahead.
Daewoong Pharmaceutical plans to speed up its push into Southeast Asia with this approval. Indonesia, with a population of about 280 million, is the largest market in Southeast Asia and is considered a key country that global drugmakers prioritize when entering the region. As of 2024, the anti-ulcer market is about $154.95 million and is growing at an average annual rate of about 6%.
Chief Executive Park Seong-su said, "Approval in Indonesia is an important inflection point for global expansion," adding, "We will continue to expand overseas markets based on our accumulated approval experience and clinical data."